The father of Toku CEO and co-founder Ehsan Vaghefi was blind at four from congenital glaucoma. Thus, his father joined the Iranian Blind Foundation. VAGHEFI says most of his childhood friends were blind or had blind parents.
Vahefi considered becoming a clinician to help people like his father, but he wanted to see how technology could help more people. He founded Toku to study ocular imaging’s diagnostic potential after switching to health tech.
“Early in life, I understood that if I became a clinician, I would be limited by the number of hours in my day, and [I] made it my mission to bring health to the masses through technology and innovation,” said Vaghefi, an associate professor of optometry and vision science at the University of Auckland with five patents, 50 publications, and more than $15 million in grants in early detection research.
“I have worked every day of my adult life relentlessly to bring affordable and accessible disease screening to everyone, everywhere, so no child would grow up with a disabled or deceased parent.”
Toku begins by stating that glaucoma is strongly linked to heart-related conditions, so examining a patient’s eye can reveal their cardiovascular system. Its main product, CLAiR, is a non-invasive, AI-powered retina scan and technology platform that can detect cardiovascular risks and diseases like stroke and type 2 diabetes.
CLAiR uses AI to “read” tiny signals from retinal blood vessels to calculate heart disease risk, hypertension, and high cholesterol in 20 seconds, according to Toku. The platform integrates with retinal imaging cameras, making its diagnostics part of any routine eye exam.
The company raised $8 million in Series A funding earlier this year from National Vision and Topcon Healthcare. However, it is early.
CLAiR, which works with retinal imaging cameras, received “breakthrough device status” from the FDA earlier this month.
The CEO said the FDA’s breakthrough device designation “significantly shortens the de novo process” to market. Toku has access to “a designated FDA team of experts working with the startup to de-risk the accreditation process,” he said.
“Every product that receives final FDA approval through the breakthrough designation program can receive an automatic CPT reimbursement code immediately,” Vaghefi said.
The downside is that it’s not yet available. The startup claims it will be the first U.S. medical device company to offer an affordable, non-invasive CVD risk assessment using retinal images, if FDA-approved.
The 20-person startup began in Auckland, New Zealand, in 2019. Early this year, it moved its headquarters to San Diego.
Toku plans to start its pivotal trial in mid-2024 and launch by 2025. It is preparing for that rollout with strategic backers like Topcon Healthcare and National Vision after approval.
Toku isn’t the first startup to use retinal analysis to predict cardiovascular disease.
Google and Alphabet’s Verily announced five years ago that they were developing an AI algorithm to predict heart disease risk from eye scans. However, it has yet to launch. The AI tool could also replace CT scans, MRIs, and X-rays. Another South Korean startup, MediWhale, uses AI to diagnose cardiac and kidney disorders with a non-invasive retina scan.
Toku will be used at retail optometry, primary care offices, ophthalmology clinics, and pharmacies with retinal cameras by asymptomatic adults with routine eye exams.
CLAiR will refer high-risk cardiovascular patients to their primary care providers for further testing. For its privacy and data retention policy, Toku said it follows HIPAA and ISO 13483 to restrict access to patient health data.
“We do not use patient information for research or AI training unless explicitly stated,” the CEO said. “The patient can request data deletion at any time, and it will be done immediately. We use local servers and infrastructure in every jurisdiction to comply with data sovereignty.”